Nakamura Y, Yamaoka O, Uchida K, Morigami N, Sugimoto Y, Fujita T, Inoue T, Fuchi T, Hachisuka M, Ueshima H, Shimakawa H, Kinoshita M
Shiga University of Medical Science, Seta, Otsu, Japan.
Cardiovasc Drugs Ther. 1996 Sep;10(4):475-83. doi: 10.1007/BF00051114.
We conducted a multicenter prospective, randomized, double-blind, placebo-controlled trial to test whether pravastatin, a hydroxymethyl glutaryl coenzyme A reductase inhibitor, can decrease restenosis after percutaneous transluminal coronary angioplasty (PTCA). Pravastatin 10 mg twice daily was begun at least 10 days prior to elective PTCA in patients with total cholesterol less than 280 mg/dl. The end-point was a between-group comparison of the frequency of restenosis defined as a more than 50% loss of the initial gain in diameter stenosis at the PTCA site at 3 months during follow-up by automated quantitative coronary arteriography. Of 207 patients randomly assigned to study groups, 139 patients underwent PTCA; 133 procedures were successful, and 124 patients underwent follow-up angiography at 3 months, and 179 lesions (85 pravastatin, 94 placebo) in 124 patients (62 pravastatin, 62 placebo) were analyzed. The two groups were comparable for baseline characteristics. Total cholesterol decreased by 19.6% in the pravastatin group (p < 0.001) but not in the placebo group. Although the restenosis rate was not different in the two groups (29.4% in pravastatin vs. 39.4% in placebo, p = 0.215) as a whole, it was reduced to about one fifth (8.8%) in the pravastatin group compared with 44.8% in the placebo group (p = 0.0011) when the comparison was restricted to high grade lesions (> or = 75% diameter stenosis, 34 lesions in pravastatin, 29 lesions in placebo). Pravastatin thus reduces restenosis after PTCA of high grade lesions.
我们进行了一项多中心前瞻性随机双盲安慰剂对照试验，以检验羟甲基戊二酰辅酶A还原酶抑制剂普伐他汀能否降低经皮腔内冠状动脉成形术（PTCA）后的再狭窄发生率。对于总胆固醇低于280mg/dl的患者，在择期PTCA至少10天前开始每日两次服用10mg普伐他汀。终点是通过自动定量冠状动脉造影术对随访3个月时PTCA部位直径狭窄初始增益损失超过50%定义的再狭窄频率进行组间比较。在随机分配到研究组的207例患者中，139例接受了PTCA；133例手术成功，124例患者在3个月时接受了随访血管造影，对124例患者（普伐他汀组62例，安慰剂组62例）中的179处病变（普伐他汀组85处，安慰剂组94处）进行了分析。两组的基线特征具有可比性。普伐他汀组总胆固醇下降了19.6%（p<0.001），而安慰剂组未下降。虽然总体上两组的再狭窄率没有差异（普伐他汀组为29.4%，安慰剂组为39.4%，p=0.215），但当比较仅限于高级别病变（直径狭窄≥75%，普伐他汀组34处病变，安慰剂组29处病变）时，普伐他汀组的再狭窄率降至约五分之一（8.8%），而安慰剂组为44.8%（p=0.0011）。因此，普伐他汀可降低高级别病变PTCA后的再狭窄发生率。
